Quite frankly, we don’t understand the process. Scientific discovery is not a onetime event; it’s a complex winding road with many trials and errors along the way. Instead, most of us expect each new study and each new headline to bring final certainty, but science is cumulative. “Only one in fifty reported scientific breakthroughs is a real breakthrough,” noted one science journalism professor in Germany. What science does provide is a consensus of experts, based on the evidence they’ve accumulated and analyzed. Take smoking. Even now, certain elements of tobacco science remain unclear, such as why some smokers get lung cancer and others do not. Yet as a complete scientific body of knowledge, we know that cigarettes cause cancer and even secondhand smoke is harmful. No one doubts that fact today, regardless of the elements of uncertainty that remain unproved by science. The consensus of expert advice favors breast milk as the normal food for babies.
Doubt-mongering works—as it did in the past for smoking and does now with climate change—in part because we don’t understand what it means to say something is a cause. We think it means that if A causes B, then if you do A, you will get B. As in, if smoking causes cancer, then if you smoke, you will get cancer. But that is not the case. We all know someone who smoked for years and never got cancer. In science, there can also be a statistical cause, in the sense that if you smoke you are more likely to get cancer. Or if you breastfeed, your infant is less likely to have severe infections. Uncertainty is a part of science. But it also makes it vulnerable to being misrepresented. Knowing this, infant formula companies and the ancillary industries repeatedly twist normal scientific uncertainty into a way to undermine the validity of actual scientific knowledge. This is dangerous and wrong.
Meanwhile, despite the efforts to manufacture uncertainty about the power of breast milk and to show there are insignificant differences in breastfed and formula-fed babies, infant formulas spend a lot of money and time seeking patents for human milk composition and stockpiling breast milk with plans to emulate it as best as possible. In a recent analyst conference call, Mead Johnson CEO Jakobsen, boasted that at Mead Johnson “we operate the largest breast milk bank in the world where we regularly collect breast milk from all over the world.” Even with their patents and thousands of gallons of mother’s milk for research, there has not been one study proving infant formula to be better than breast milk. There is absolutely no evidence that infant formula improves the health of mothers or babies. As Dr. Kramer said to me in a 2013 interview: “The bottom line is that nobody has shown that formula feeding is better for any health outcome in the mother or the baby. If you take that as the bottom line—that nobody has demonstrated that formula is better for the mother or the baby for anything—then the rest, in a way, is irrelevant.”
The Infant Formula Breakthrough
The dangerous relationship between science and breastfeeding is not just about breast-milk research. The field of science has worked tirelessly and benefited handsomely from applying scientific innovation to the quest to replicate and replace mother’s milk. One of the biggest wins for infant formula was the development of synthetic versions of DHA and ARA, two long-chain fatty acids found naturally in breast milk that are known for their benefit to brain and eye development. DHA, which stands for docosahexaenoic acid, is a polyunsaturated fatty acid of the omega-3 family. This particular fatty acid is concentrated in the cells of the human brain and in the membranes of the retinal photoreceptors in the eyes. ARA is short for arachidonic acid, which is an omega-6 fatty acid.
The synthetic version of the DHA and ARA oils were first created in 1999 by Martek Biosciences Corporation and were quickly introduced as an additive to infant formula. Their patented, genetically modified oils are called DHASCO (docosahexaenoic acid-rich single-cell oil) for the synthetic DHA and ARASCO (arachidonic acid-rich single-cell oil) for ARA, both marketed under the brand name Life’s DHA. The breakthrough created a financial windfall for the infant formula makers as they laid claim to actually mimicking the complexities of mother’s milk. Even before the additive oil made it into a bottle, Martek was clear about the marketing potential for convincing parents that infant formula was close to breast milk. The company’s own 1996 investment promotional materials said, “Even if [the DHA/ARA blend] has no benefit, we think it would be widely incorporated into formulas as a marketing tool and to allow companies to promote their formula as ‘closest to human milk.’” Since officially hitting the market in 2002, almost all brands of formula sold in the United States are now fortified with DHASCO and ARASCO oils.
Turns out, the process for replicating what naturally occurs in breast milk is not very natural at all. The breasts do not need anything to make DHA and ARA. But in a lab, the DHA is extracted from fermented microalgae and the ARA is extracted from soil fungus—items that are not even part of a human diet. To be exact, Martek ferments laboratory-grown algae and fungus, extracting the DHA with hexane, a neurotoxic petroleum-based solvent, then bleaching and deodorizing it before making it into powder form. The AHA additive, ARASCO, is obtained from the Pythium insidiosum or Mortierella alpine species of fungus, using a similar production and extraction process. Not very natural. Fungal food sources have the potential of acting as opportunistic pathogens in individuals with compromised immune systems, doctors say. Hexane is considered a neurotoxin and a hazardous air pollutant. It is a chemical by-product of gasoline refining and is also used as a solvent for glues, varnishes, and inks and as a cleaning agent in the printing industry. The possible long-term dangers of algae, fungus, and rocket fuels in our babies are not yet known, but most formula-fed babies ingest it every time they have a bottle. The benefits to babies is still unclear.
An extensive review of synthetic DHA and ARA research was published in the Journal of Nutrition. As far back as 1997, the research concluded that there was not enough evidence to support the addition of these fatty acids to formula. In animal studies, there were reported side effects such as oily, soft stool and oily hair. After four weeks, rat pups had higher liver weights; after three months, they showed elevated serum alkaline phosphatase (ALP) levels, which are linked to liver and bone disease.
The algae DHA is not identical to what is found in human milk. Human fatty acids are structurally different from those manufactured from plant sources, and the acids interact with one another in a very special matrix. Just because human fatty acids perform as they do in human milk does not mean they will perform the same way in an artificial construct.
The Food and Drug Administration, charged with keeping our food supply safe, accepted Martek’s claims about the safety and effectiveness of its synthetic fatty acids instead of making its own independent assessments. The oils were allowed onto the market with the stipulation that they would be monitored and a caution that the scientific evidence on the benefits of these additives was mixed. This means “give the formula to as many babies as possible and see what happens.” Since the clinical trials (experiments on babies) were done on small numbers, this allows the formula companies to have access to the entire population of babies born in the United States every year: four million unsuspecting infants and their misinformed parents.
According to a panel of independent scientists convened by the Institute of Medicine, premarket safety tests for these DHA/ARA oils were inadequate. The panel concluded that insufficient safety tests were performed. Certain tests were performed only on rats, when they should have been performed on nonhuman primates as well. No chronic toxicity or chronic carcinogenicity studies were performed, not even on rats. In fact, none of the “long-term” safety tests lasted for more than ninety days. The real testing is being staged on a generation of unsuspecting babies—putting infant health on the line to boost profits. This represents an enormous uncontrolled experiment that bypasses informed consent and is being supported by many health care professionals who are wedded to the infant formula industry. Infant formula with DHASCO/ARASCO is priced at 15 to 30 percent more than standard formula. The International Baby
Food Action Network (IBFAN) estimates that infant formula supplemented with DHASCO/ARASCO costs parents an additional $200 per year. There is no way to quantify how the misleading marketing of infant formula as having breast-milk-like qualities contributes to low breastfeeding rates in this country.
The biggest financial benefactor has been Enfamil, made by Mead Johnson, which was the first to add artificial DHA and ARA and market them as magical nutrients in their formula. Enfamil advertisements declared “Enfamil LIPIL improves brain development. No other formula gives your baby the best start in life.” The fact that infant formula makers plow millions into simulating the components of breast milk and use breast milk as the substance they seek to emulate should speak volumes about the superiority of breast milk. Pepsi would never say it is trying to be as good as Coke—that is a de facto endorsement of Coke.
Another advertisement said, “Enfamil PREMIUM is clinically proven to result in IQ scores that are similar to those of breastfed infants.” In order to be “clinically proven,” findings from a clinical trial must be repeated and corroborated by other scientists. This did not happen. Mead Johnson based its IQ claims on the results of one clinical trial, conducted by scientists affiliated with the Dallas-based Southwest Retina Foundation. In a 2007 publication, they shared their results: children who were fed formula with DHA and ARA during the first seventeen weeks of life had visual acuity and IQ scores similar to breastfed infants. This team of scientists was sponsored by Mead Johnson (maker of Enfamil), which has, over the years, supplied free formula for trials and granted more than $1 million to support research. Since that sponsored study, no other clinical trial to date has found any benefit to these synthetic additives. In fact, almost twenty other clinical trials found that adding synthetic DHA and ARA in formula provides no benefit in mental and visual development.
Meanwhile, parents and medical professionals continue to report negative reactions in babies fed with formula products containing synthetic DHA and ARA. In 2011 the FDA announced it would investigate claims that DHA-ARA infant formulas support brain and eye development.
In the meantime, Life’s DHA is still being sold in many regular and so-called organic brands, which many consumers trust. From Martek’s own Web site, here is a list of infant formulas containing their product, which is both genetically modified and typically manufactured using a known toxin:
Earth’s Best Organic Soy with DHA & ARA (Hain Celestial Group)
Enfamil LIPIL (Mead Johnson)
Enfamil Next Step (Mead Johnson)
Isomil 2 Advance (Abbott)
Nestlé Good Start Supreme with DHA & ARA (Nestlé USA)
Parent’s Choice Organic (Wal-Mart)
Similac Advance (Abbott)
Ultra Bright Beginnings Lipids (PBM Products, LLC)
These brands are included in at least ninety-eight reports of adverse reactions filed with the FDA by parents and doctors. The Cornucopia Institute, a nonprofit focused on social justice in the food chain, requested copies of the reports through a Freedom of Information Act request, as part of their Organic Integrity Project. The adverse reports ranged from constipation and bowel obstruction to vomiting and diarrhea, as infants endure months of pain and fussiness and parents face months of anxiety and distress. In some cases it was not possible to determine if the reported problems were due to bacterial contamination of the formula, lactose intolerance or allergies, or other problems commonly experienced with infant formula. Although a clear link could not be established, there is still the potential that DHA and ARA oils are implicated in some of these cases. The adverse-reaction reports represent only the tip of the iceberg, especially since most parents remain unaware that Martek’s DHA and ARA oils may be the cause of their infant’s problems. Some parents and their babies have endured symptoms for weeks or months before identifying the cause, believing it was simply colic or unexplained fussiness. In reality, babies are needlessly sick in part because of a scientific endeavor to mimic mother’s milk for the sake of greater profits. Imagine if the millions wasted on developing and marketing a potentially dangerous substitute was spent on creating the policies and resources mothers needed to easily nurse their own babies and then making sure any necessary substitutes were as rigorously tested as possible. Instead, misleading infant formula production and marketing is often viewed as a victimless crime and therefore not a serious problem.
Whether we are examining the scientific research on breast milk or the application of scientific advances to replicating breast milk, it seems that mothers and infants lose. Do we know everything about breast milk? No. Breast milk is a complex, living substance brimming with live cells, enzymes, and bioactive compounds. Lactation and human milk remain some of the least researched aspects of human functions. Have some advocates overemphasized the health benefits that have been proved by science? Probably. Even Kramer noted this dangerous misstep in our interview. “There’s no question that the science overall supports the benefits of breastfeeding. But the arguments against the research question if all of the benefits attributed to breastfeeding have been equally well-documented scientifically. And the answer is no,” Kramer says.
Here’s what we do know: doubt-mongering works, commercial interests thwart what’s best for public health, and our concept of what scientific evidence means can be severely flawed. We only need to look at our failures to act decisively in response to the body of scientific evidence on tobacco, acid rain, and global warming. Go back to 1969, and the now infamous memo written by an executive from the tobacco giant Brown & Williamson: “Doubt is our product.” Thirty-seven years later, U.S. district judge Gladys Kessler found that the tobacco industry had “devised and executed a scheme to defraud consumers and potential consumers” about the hazards of cigarettes. These were hazards that their own internal company documents proved they had known since as early as 1953 and yet they consistently conspired to suppress this knowledge. Their indictment, under the RICO Act (Racketeer Influenced and Corrupt Organizations) was based on overwhelming evidence that they led an intentional campaign, initially spearheaded by the high-powered public-relations firm they hired, to fight the facts and to sell doubt. Their chief objective was to protect the highly profitable business of tobacco sales. The health of Americans was never a consideration.
Their insidious campaign relied heavily on industry-sponsored science—hiring scientists and funding research to create their own so-called evidence. The tobacco industry’s position was that there was “no proof” that tobacco was bad, and they fostered that position by manufacturing a “debate,” creating their own research and then convincing the mass media that responsible journalists had an obligation to present “both sides” of the issues. As part of their doubt-mongering strategy, tobacco companies used scientists who appeared to be independent, when, in fact, many of the payments from tobacco companies were channeled through other organizations and special-interest groups. External research was used to bolster the industry’s position that the public should decide for themselves and that government was interfering in the personal lives of Americans. Then they created front groups with names suggestive of public-interest groups and began what became a standard industry practice of hiring various think tanks and consulting firms to defend their products. Does any of this ring a bell? The whole strategy is eerily similar to the tactics deployed by the infant formula companies. The plan to create doubt that breast milk is actually better than formula is a business strategy. It is not a public health directive or the result of the actual scientific body of evidence. Much of the so-called scientific debate over the benefits of breast milk is not waged for the sake of women’s ability to choose, it is for a company’s ability to churn profits, which they plow back into industry-sponsored research to bolster the likelihood of outcomes that serve their profit-making needs. Over time, this faulty science becomes part of systematic reviews and other study methodologies.
This science can be used to shape national policy. Consider the governmen
t’s dietary guidelines (DGA). According to the 1990 National Nutrition Monitoring and Relation Research Act, every five years, the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture must jointly publish nutritional and dietary information and guidelines for the general public based on current scientific and medical knowledge. The guidelines are used to shape the makeup of federal food assistance programs, such as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), and help determine which foods are chosen for the USDA’s National School Lunch Program and School Breakfast Program. These guidelines are the basis for federal food programs, recommended diets for pregnant women, and are used to set health policies as well as serve as the foundation of national nutrition education for the public. In a nutshell, they are powerful and influence the diets of millions of Americans. At least for Americans over the age of two. For years, the guidelines have ignored the youngest Americans, skipping over the critical period of infancy to twenty-four months.
The Big Letdown Page 10
